SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

Study acronym: CRIC
StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Minor Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: 57 to 58
  2. 2 versions Re-verified since Nov 11, 2025, no change to tracked fieldsv30-v31
  3. Minor Eligibility criteria revisedv29
  4. Re-verified, no change to tracked fieldsv28
  5. Notable Primary and study completion dates: Jun 2023 to Jun 2028
    • Enrollment target: 5112 to 5499
    • Study description shortened, about 14 words
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. Re-verified, no change to tracked fieldsv26
  2. Minor Study sites: 13 to 12v25
  3. Minor Study description expanded, about 2 wordsv24
  4. Minor Study description expanded, about 468 wordsv23
  5. Re-verified, no change to tracked fieldsv22
  6. Minor Study description shortened, about 15 wordsv21
  7. Notable Primary and study completion dates: Jun 2018 to Jun 2023v20
  8. Minor Primary completion date: Dec 2017 to Jun 2018v19
  9. 2 versions Re-verified since Aug 18, 2016, no change to tracked fieldsv17-v18
  10. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 13 of 13 sites
    v16
  11. Minor Study sites revised (13)v15
  12. Minor Site details revised at 2 of 13 sitesv14
  13. Re-verified, no change to tracked fieldsv13
  14. Minor Site details revised at 1 of 13 sites
    • Publications: 9 to 57
    v12
  15. Notable Trial status: Active, Not Recruiting to Recruitingv11 Show 7 more changesShow less
    • Enrollment target: 3834 to 5112
    • Primary completion date: Dec 2017
    • Study completion date: Jun 2008 to Jun 2018
    • Eligibility criteria expanded, about 84 words
    • Study description shortened, about 59 words
    • Study sites revised (13)
    • Collaborators revised (7)
  16. Notable Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to University of Pennsylvania
    • Collaborators revised (7)
    v10
  17. 2 versions Re-verified since Oct 2, 2008, no change to tracked fieldsv8-v9
  18. Minor Trial status: Recruiting to Active, Not Recruitingv7 Show 5 more changesShow less
    • Enrollment target: estimated 3300 to confirmed 3834
    • Study completion date: Dec 2009 to Jun 2008
    • Site details revised at 13 of 13 sites
    • Collaborators expanded, about 25 words
    • Publications: 7 to 9
  19. 3 versions Re-verified since Sep 5, 2006, no change to tracked fieldsv4-v6
  20. Minor Site contacts updated at 1 of 13 sitesv3
  21. Minor Study sites: 3 to 13
    • Study completion date: Dec 2009
    • Study description expanded, about 307 words
    • Publications: 6 to 7
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage kidney disease (ESKD) and the disproportionate risk of cardiovascular disease (CVD) and associated complications. CKD is strongly and independently associated with CVD, even after adjustment for traditional CVD risk factors. This led to the hypothesis that other risk factors augment the rate of CVD in the setting of CKD. Hence, many patients with progressive renal disease succumb to fatal CVD events before they need renal replacement therapy. The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study in 2001 with the initial goal of elucidating the relationship between CKD and CVD. Since its inception, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of over 5,000 participants with reduced kidney function from 13 clinical recruitment sites across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD. The CRIC Study has examined a broad set of etiological factors (clinical, behavioral, and biomarker-associated) potentially responsible for both progressive CKD and CKD-related morbidities, especially those early in the course of CKD. Characterizing relationships between these risk factors and outcomes should facilitate identification of high-risk subgroups with CKD and guide enrollment into preventive treatment trials and application of preventive therapies. Over time, the scientific focus and the CRIC investigator network have broadened extensively through a highly successful ancillary studies program that has included more than 100 projects, most of which have been funded through federal grants. To date, the CRIC Study's investigative activities have resulted in over 300 published scientific papers with many additional manuscripts in development.
Trial Details
NCT Number NCT00304148
Lead Sponsor University of Pennsylvania
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University, Case Western Reserve University, University of Michigan, University of Illinois at Chicago, Tulane University, Kaiser Permanente
Conditions
(from sponsor)
Renal Insufficiency, Chronic
Related terms Renal Insufficiency, Chronic
Enrollment 5,499 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov